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    CAVEAT EMPTOR:Decision Making on Clinical Technology Acquisitions

    Wednesday, April 15 – 11:30am-12:30pm 

    Stephen L. Grimes, FACCE FAIMBE FHMISS

    Chief Technology Officer,

     ABM Healthcare Support Services

    DISCLAIMER: The views and opinions expressed in this presentation are those of the author and do not necessarily represent official policy or position of HIMSS.

    Jacob B Johnson, MS CCE

    Manager, Clinical Technology Integrated Systems Management

    Kaiser Permanente

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    Conflict of Interest 

    Stephen L. Grimes, FACCE FAIMBE FHIMSS

    Has no real or apparent conflicts of interest to report.

    © HIMSS 2015

    Jacob B. Johnson, MS CCE

    Has no real or apparent conflicts of interest to report.

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    Session Description

    Capital budgets for clinical technology acquisitions today is often 8 to

    10 times larger than what same organization spent 10 years ago.

    This session provides a description of a structure, process, and tools 

    that decision makers (CEOs, COOs and CFOs) should avail themselves

    of when determining which clinical technologies to adopt and how tomeasure a successful implementation.

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    Learning Objectives 

    1) Explain why the challenge of clinical technology acquisitions today

    represents a major shift from acquisitions of only a few years ago

    2) Identify best sources of objective information that decision makers

    should typically consult before selecting and deploying new clinical

    technologies

    3) Describe a scalable structure, process, and set of tools that facilitates

    the smart selection and adoption of new clinical technologies

    4) Describe how to establish key objectives related new clinical

    technologies under consideration and how to assess the level of

    success achieved following deployment

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    Today’s Challenge 

    trend in annual spend for biotech and related purchases (as reported

    by CEO of KP) for One Health Plan has increased > 9 times ($62.3M

    to $580M) between 1997 and 2007  … and that trend is likely to

    continue rising for healthcare organizations

    implementation of new medical technology accounts for between 38

    percent and 65 percent of health care spending increases between

    1985 and 2006.‡ 

    rapid evolution of new and complex technologies (e.g., hybrid ORs,

    radiosurgical systems, robotic surgical systems, 3D imaging, real-time

    vital sign monitoring for general patient population, etc.) poses

    significant challenges for organizations who strive to adopt

    technologies that both broaden and improve patient care services

    while better managing costs

    Source: Halverson, George C., “Healthcare will not reform itself.” CRC Press. 2009. pg 22

    ‡ Source: http://www.rwjf.org/content/dam/farm/reports/issue_briefs/2011/rwjf71331 

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    What’s driving the increases?Complexity Drives Higher Implementation and Support Cost

    Medical Devices

    Networked Systems

    System Integration

    Features Sold as “Value Added

    Capabilities” often drive cost for

    Implementation and Support

    Complex

    Simple 

       C  o  m  p   l  e  x   i   t  y

    Total Cost

    Trends:

    Increasing Customization Options

    Software Subscription Model

    Wearable & Disposable sensors

    Trends:

    WAN Functionality

    Customer Supported Network

    Mobile & Wireless Use Cases

    Trends:

    System/System Bi-Directional

    Automated Workflows

    Business Intelligence

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    Planning

    Install

    VendorSupport

    Parts &Consumables

    PurchasePrice

    IT/CE Support

    Security Infrastructure

    ClinicalFunctionality

    TrainingRequirements

    Upgrades

    DataIntegration Costs less Commonly

    Managed by Sourcing

    Teams

    More Specialized

    Resources required to

    Assess

    Commonly Evaluated

    and Negotiated by

    Sourcing Teams

    Costs

    RelativelyStable

    Source of

    Spending

    Increases

    What’s driving the increases? 

     Acquisition Cost is Only the Tip of the Iceberg

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    Technology AcquisitionsImpact from Discrete (one patient one device) to Enterprise

     Across

    Continuum

    of Care

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     A Structure for Making Effective

    Clinical Technology Acquisition Decisions

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    Healthcare Technology Assessment Committee

    To address the challenge of identifying healthcare

    technologies for acquisition, this organization should

    establish a Healthcare Technology Assessment (HTA)

    Committee 

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    Rationale for HTA Committee

    increasingly new technologies are having a ripple effect on an

    organization’s clinical, support, and business operations

    new technologies can also have a major impact on the

    organization’s financial resources.

    growing need to give appropriate consideration to the strategic,

    clinical, safety, operational, and financial implications prior to

    acquisition

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    HTA Committee Purpose

    take a strategic view

    focus on evidence-based consideration of technology acquisition

    engage appropriate stakeholders ... including those who

    understand how to analyze and plan deployment and workflow

    processes can identify required support infrastructure & associated costs

    establish appropriate justification process & metrics relevant to

    organization’s goals 

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    Example of HTA Committee Structure

    Multidisciplinary team (with ad-hoc representation):

    Department Chairs/Directors (owner/operators of equipment)

    Chief Medical Officer (CMO)

    Chief Medical Informatics? Officer (CMIO)

    Chief Nursing Officer (CNO)

    Chief Executive or Operating Officer (CEO/COO)

    Chief Financial Officer (CFO)

    Director of Supply Chain / Materials

    Director of Healthcare Technology Management / Clinical Engineering

    Chief Information / Technology Officer (CIO/CTO)

    Additional committee support staff includes senior experts in information

    services, quality, compliance and risk management.

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    LeadershipTeam

    CEO

    COO

    CTO

    CMO

    CFO

    Clinical

    DepartmentChairs/Managers

    Clinical EndUsers

    MedicalInformatics

    Technical

    ClinicalEngineering

    InformationTechnology

    Supply Chain

    Finance

    Financial Analylst

    Revenue Cycle

    Property Accounting

    Sourcing,

    Risk &Quality

    Sourcing

    Quality

    Compliance

    Risk Management

    Legal

    Example HTA Committee Structure

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    Leadership

    Team

    Defines Strategy,Goals & Objectives

     Allocates

    Resources toCommittees

    Ensures BalancedDecision Making

     Approves

    Contracts &Expenditures

    Clinical

    Defines ClinicalNeeds &

    Opportunities

    Provides Clinical

    Workflow & EndUser Expertise

    Defines ClinicalTraining

    Requirements

    Champions PatientPerspective

    Technical

    Forecasts & Plansfor New

    Technologies

    Defines TechnicalRequirements

     AssessesCapabilities &Value-Adds

    Defines Installationand Support

    Strategy

    Provides Inventory& Cost of Service

    Data

    Finance

     Analyzes andValidates Financial

    Benefits & Risks

    Manages &

    Reports SpendForecast

    Supports year-over-year

    investment strategy& budgeting

    Sets Metrics to

    analyze HTAperformance

    Sourcing,Risk &

    Quality

    Manages VendorEngagement,Negotiation,Compliance

    Provides Risk and

    Quality data foranalysis

    Ensures adherenceto policy,

    regulations andrequirements

     Advises on Risks &

    BusinessContinuity

    Example HTA Committee Roles

    Champion Implementation of Strategies

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    HTA Committee Goals & Metrics

    The HTA committee considers goals and establishes metrics that

    can demonstrate progress to goals. Examples of goals include:improved care outcomes

    improved patient/staff safety

    reduced data security risks

    improved regulatory compliance

    improved efficiency & workflow processesimproved revenue, particularly improvements with P4P initiatives

    reduced costs

    improved technology reliability

    improvements in utilization & longevity

    greater technology & vendor standardization to reduce support costsbroader patient demographic served

    improved market perception (reputation)

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     A Process for Making Effective

    Clinical Technology Acquisition Decisions

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    The Acquisition Process

    The Joint Commission Comprehensive Accreditation and

    Certification Manual (EC.02.04.01, EP1)“The hospital solicits input from individuals who operate and service equipment

    [e.g., HTM/CE services, IT] when it selects and acquires medical equipment .”  

    Acquisition process should be systematic & meaningful …

    the acquisition process should consider

    is proposed equipment new or replacement?

    does similar equipment already exists in organization?

    who and what areas will be affected by acquisition?

    what goals are to be achieved by the acquisition and how is

    successful achievement of those goals to be measured (metrics)?

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    The Acquisition Processprospective owner

    submits a request for new

    (or replacement equipment)

    along with justification to

    COO/CFO for preliminary

    approval

    if preliminary approval given by

    COO/CFO, request/justification form

    is submitted to HTA committee

    HTA committee conducts an

    appropriately detailed assessment

    of request & justification, evaluates

    the degree to which the requested

    equipment meets one or moreorganizational goals and makes

    recommendations to the COO/CFO

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    The Acquisition Processif an acquisition is approved by the

    COO/CFO, materials management

     /supply chain works with users,

    HTM/CE services and other relevant

    stakeholders (e.g., IT, facilities) to

    establish an acquisition timetable

    determine detailed requirements

    (to be incorporated in RFP

    purchase order) and

    evaluate/select the product and

    vendor (thru RFP)

    the selected vendor is given an order

    including established

    specifications/requirements

    roles & responsibilities for deployment,

    installation, workflow design, training &

    support are detailed & formalized

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    Tools for Making Effective

    Clinical Technology Acquisition Decisions

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    Key Acquisition Tools

    Capital Medical EquipmentRequest & Justification Form

    Acquisition Requirementsfor Medical Equipment

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    Medical Equipment Request and Justification Form

    Requestor InfoProduct & Vendor Info

    Description, Manufacturer, Model, Cost?

    Does other equipment from this manufacturer & model already exist?

    If yes, how many & where?

    Vendor

    name

    is this vendor already vetted?

    is this vendor a participant in one of organization’s group purchasing organizations? 

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    Medical Equipment Request and Justification Form

    Funding SourceOther Initial Costs Beyond Acquisition

    (estimated)

    additional staff

    operator training

    maintenance training

    facility modifications

    additional equipment

    Projected Annual Costs maintenance (post warranty)

    software upgrades/ license fees

    supplies & Consumables

    utilities (electric, water, gas,

    network, etc.)

    operators & operator support …

    including cost of on-going user

    training

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    Medical Equipment Request and Justification Form

    New equipment?

    Does new equipment

    provide new (or expand existing) service or provide needed new features?

    facilitate patient care and/or workflow improvements?

    provide important safety improvements?

    other justifications?

    Will there be a sufficient amount of utilization to support its acquisition and allowfor user proficiency to develop? Users get good at what they do frequently

    (practice or live).

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    Medical Equipment Request and Justification Form

    Replacement equipment?

    Does the existing equipment

    have insufficient features/functions

    for current or projected clinicalneeds?

    have insufficient capacity foranticipate workload?

    have unresolvable safety issues?

    technically unreliable?

    too costly to support?

    approach clinical and/or technical

    obsolescence? approach end of manufacturer

    support?

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    Medical Equipment Request and Justification Form

    Other considerations – Are there

    special data security needs?

    monitoring needs (important alarms/alerts)?

    space needs?

    environmental needs?

    special utility needs?

    network or internet access needs?

    special cleaning or infection control needs?

    appropriate guidelines for alarm/alert settings

    di l i d ifi i

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    Medical Equipment Request and Justification Form

    Metrics

    description of principal benefit(s) of acquiring

    equipment

    projected utilization

    description of timetable for achieving benefit(s)after acquisition?

    description of means to measure benefits gained

    Pillars

    service

    people

    quality

    financial

    growth

    community

    M di l E i R d J ifi i F

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    Medical Equipment Request and Justification Form

    Required reviews /sign-offs … does the proposed system 

    require a network or internet connection, software, integration to EMR?

    represent a device/system used in treatment, diagnosis or monitoring?

    represent a device/system that either is new technology or has a broad effect on care?

    requires installation, facility modification, special environmental considerations, utilities?

    R i t f A i iti f M di l E i t

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    Requirements for Acquisition of Medical Equipment

    Next 3 slides should be considered “minimum” requirements 

    …. 

    ...

    R i t f A i iti f M di l E i t

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    Requirements for Acquisition of Medical Equipment

    Minimum requirements for warranty service documentation

    ...

    R i t f A i iti f M di l E i t

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    Requirements for Acquisition of Medical Equipment

    Signed/agreed to by vendor … and stakeholder who will be

    responsible for verifying compliance

    ….  ...

    P t A i iti Cl th L

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    Post Acquisition - Close the Loop

    Review the justification & metrics 6 -12 months after acquisition

    in order to inform and refine process

    C l i

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    Conclusion

    Sophistication, Complexity and Broad Impact (operational &

    financial) of today’s clinical technologies on an organization is

    too significant not to include informed stakeholders in theacquisition process and decision

    Strategic, systematic, objective evidence-based approach with

    input from informed stakeholders needs to be norm for future

    clinical technology acquisition decisions

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    Conclusion:Rationale for Investing in Healthcare Technology Assessment

    MedicalTechnology

    Lifecycle

    Vision-

    StrategyPolicy

     Assessment

    Plan  – Design-Budget

     Acquire  – Procure

    Build-Deploy

    OperateMaintain

    Refresh  – Redeploy  – 

    Retire/

    Ensure Acquisitions align with

    Organizational Strategies andFinancial Goals

    Evaluate Technology Capabilities,Benefits, Risks and RiskMitigation strategies.

    Understand Impact to Clinicaland Business Workflows

    Understand infrastructure andresource needs to achieveBenefits Realization

    Define Implementation and

    Ongoing Support Requirements

    Balance Total Cost of Ownershipwith Business and Clinical Needs

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    Thank You!

    Questions? 

    Stephen L. Grimes, FACCE FAIMBE FHMISSChief Technology Officer,Healthcare Technology Management DivABM Healthcare Support [email protected] 

    (617)756-9088

    Jacob B Johnson, MS CCEManager, Clinical TechnologyIntegrated Systems Management

    Kaiser [email protected] (510)414-2435)

    mailto:[email protected]:[email protected]://healthy.kaiserpermanente.org/html/kaiser/index.shtmlmailto:[email protected]:[email protected]